scope:

Provides guidance on the implementation of EN 29001 and EN 46001 and of EN 29002 and EN 46002 as applied to the manufacturer of IVDs. It is aimed at affording a better understanding of the standards themselves as well as assistance in their use, either in implementing or evaluating such a quality system. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be drawn. The adoption of systems other than those described in this standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the particular requirements in EN 46001 and EN 46002.